3S Consulting Group, Inc.

Regulatory (FDA) Guidance

Regulatory  considerations are often critical to the success of a new product. Our  extensive experience working with regulatory agencies, including the FDA, in all areas of regulatory affairs, provides your organization with the support necessary in order for your product to be successful.

Our regulatory affairs services range from initial regulatory strategic planning, to clinical study design, to regulatory submissions. 3S can either function in a project management capacity or as a supplement/complement to your in-house regulatory team.

Regulatory Services:

  • FDA regulatory strategic planning
  • FDA liaison/negotiation/conferencing – negotiation with FDA is frequently overlooked, but often critical for timely regulatory success
  • FDA Warning Letter and Clinical Hold resolution – if the unfortunate occurs, it is important to have an experienced team readily available to achieve a timely resolution
  • FDA inspection assistance – our team is experienced in manufacturing facility and  clinical study inspections

Clinical Affairs Services:

  • Clinical Protocol design, writing and review, Phase I, Phase II and Phase III protocols, including CRF design
  • Clinical trial management – our extensive experience and collaborations provide services from investigator meetings, clinical monitor and audit
  • Investigator/study site search/match – with our extensive network and experience in the wound and skin care industry, our database will match your clinical trial needs with the best investigators/study sites

FDA Submissions:

  • Investigational New Drug Application (IND)
  • Premarket Notification (510(k))
  • Investigational Device Exemption (IDE)
  • Premarket Approval (PMA)

Manufacturing/Quality Systems:

  • Good Manufacturing Practices (GMP) implementation
  • Quality System Regulations (QSR) implementation
  • Quality audits and facility inspection